Field
The present invention generally relates to medical devices and procedures, particularly devices configured to be delivered and placed into a patient's body for treatment of pelvic organ prolapse and the method for their delivery and placement.
Description of the Related Art
Genital prolapse or pelvic organ prolapse is the protrusion of the pelvic organs into or out of the vaginal canal. Pelvic floor prolapse affects many women in the US and almost all of them undergo at least one reconstructive pelvic surgery in their lifetime. Many of the cases may be the result of damage to the vaginal and pelvic support tissue by stretching or tearing of the connective tissue within the pelvic space due to childbirth, age, obesity, post-menopausal conditions or chronically elevated intra-abdominal pressure. The results are the distention of organs such as the bladder and rectum, into the vagina, as well as various stages of vaginal avulsion.
Surgical therapy/technique is usually performed for the treatment of pelvic organ prolapse. These techniques for prolapse treatment include plication of the torn connective tissues and re-suspension of the vagina/uterus. Some traditional suspension techniques include utero-sacral suspension and sacrospinus ligament suspension. Some procedures for vaginal suspension include sacrocolpopexy, where the vagina/uterus is suspended to the sacral promontory with an implanted graft material. The grafts have demonstrated improved long-term success of the repair.
Y-shaped mesh may be used as a graft to treat vaginal vault prolapse. The Y shaped mesh aids vaginal cuff suspension to the sacrum and provides long-term support. The procedure can be minimally invasive (Laparoscopic Sacral Colpopexy) or traditional (open sacral colpopexy). These Y shaped meshes may be made of various types of polymeric or biological materials. Various doctors/operators may prefer a particular type of implant to repair the pelvic damage depending on the surgical requirements and a patient's history. Some doctors/operators may choose a biologic graft over a synthetic polypropylene graft as the biologic graft minimizes erosion as opposed to synthetic meshes. Others may prefer synthetic grafts as they provide long-term reinforcement for support structures. The existing implants are available either as a biologic graft or polypropylene graft. These implants do not include both a polypropylene and a biological material for specific usage to specific anatomical locations.
Thus, there is a need for an improved polypropylene medical device/implant having biological material at specific locations to suit the anatomical structure.